MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5525WVB
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product has been requested to be returned for evaluation, but not received.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
It was reported by a user facility in the united kingdom that during the initial stages of vitrectomy there was a significant loss of pressure and the eye was softening despite being at 35mmhg.Pressure was increased to 80mmhg to try and compensate but there was no changes.Surgeon manually inflated eye and the pressure was dropped back down to 35mmhg and the infusion line was reinserted, the eye became extremely hard.Pressure was reduced to 10mmhg but the eye remained hard.A second pack was used and the eye became soft again.The case was completed using a second system from a different manufacture.The surgery was completed with no impact to the patient except the surgery was extended 30 minutes, requiring additional anesthesia.
Additional Manufacturer Narrative
The product has been returned and the investigation is anticipated, but not yet begun.Therefore, the root cause could not be determined at this time.Review of the device history record shows product was properly made and met all release requirements.The investigation is ongoing.
Additional Manufacturer Narrative
The product was returned and evaluated.Evaluation revealed the assembly was dirty with fluid in the lines and collection cassette.The irrigation was tested and the product worked as intended.The reported problem was not duplicated.The root cause is unknown.Manufacturing and sterilization records were reviewed and found to be acceptable.Review of the device history record shows the product was properly manufactured and met all release requirements.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 18088061
• Report Number: 0001920664-2023-70121
• Device Sequence Number: 6713478
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)241106
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2024
• Device Model Number: SE5525WVB
• Device Lot Number: X4339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown